Kornimate/medical-research-clean huggingface dataset:
predicting the response to montelukast by genetic variation in asthmatics

Conditions: Asthma

Summary: the purpose of this study is to examine a specific variation in the genetic code for an enzyme (ltc4 synthase) which plays an important role in the airway inflammation associated with asthma. we hypothesize that asthmatic patients with this variant gene will have a better response to montelukast than patients with the wild type gene, as measured by the ability of montelukast to protect against a hypertonic saline challenge.

multiple genetic polymorphisms in the leukotriene pathway have been described but their clinical relevance is unclear. a single nucleotide polymorphism in the ltc4 synthase promoter region has been associated with increased ltc4 synthase mrna and a trend toward improved bronchodilatory response to leukotriene modifiers in severe asthmatics. this study will examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective response of montelukast in a double-blind, placebo-controlled cross-over fashion.

Eligibility criteria:
inclusion criteria: * male and female subjects, age 18-55 * clinical history consistent with asthma * mild to moderate asthma as determined by pulmonary function tests--60% or higher of predicted fev1 for age, sex and race. * response to hypertonic saline, which will be the main outcome variable measured. exclusion criteria: * smokers (total lifetime smoking history\>10 pack-years, any in the past year) * pregnant woman-if of childbearing age, not using an acceptable form of birth control. * use of a leukotriene modifier within the past month * use of inhaled or oral steroids within the past month. * emergency room visit for asthma exacerbation within the past 6 weeks. * intubation for asthma exacerbation in the past 10 years. * adverse reaction to inhaled beta-agonists in the past. * no recent (past 48 hours) use of anticholinergics, theophylline, antihistamines, pseudoephedrine. * patients will also be asked not to use any short acting beta-agonists for 6 hours and long-acting beta-agonists for 48 hours before their initial visit (when pulmonary function evaluation will be performed). * lung disease other than asthma * significant medical illness other than asthma

Keywords: asthma leukotriene receptor antagonist hypertonic saline challenge
follow-up study to previous care trial

Conditions: Moderate to Severe Chronic Kidney Disease

Summary: to determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with isovue®-370 or visipaque™ 320 as part of the iop-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as \>25% increase in scr or \>25% increase in cystatin c).


Eligibility criteria:
inclusion criteria: (from previous care trial) * • screening egfr between 20 and 59 ml/min/1.73m2 * baseline scr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration * at least one post dose blood sample available * received randomized contrast agent * underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by pci was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study * provides written informed consent and is willing to comply with protocol requirements; * was included in the patient list provided by bracco; * at least 1 year has passed since the patient's participation ended in the original care trial, as determined from the list provided by bracco exclusion criteria: * • screening egfr outside the range of 20 and 59 ml/min/1.73m2 * unstable kidney disease or requiring dialysis upon enrollment * prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function * did not receive randomized contrast agent per care protocol * did not undergo a cardiac angiography procedure per care protocol
nervous system infections among patients with febrile seizure

Conditions: Seizure; Febrile Seizure; Meningitis; Encephalitis

Summary: few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. none of these studies was multicentric. recommendations about management of these children are heterogeneous. the investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.


Eligibility criteria:
inclusion criteria: * febrile (\>38°) * seizure exclusion criteria: * previous non febrile seizure * known trauma * immunodeficiancy status * underlying illness
defibrotide dose-escalation for sos post-hsct

Conditions: Sinusoidal Obstruction Syndrome; Veno-occlusive Disease

Summary: this research study is being done to determine the safety and tolerability of increasing doses of defibrotide within a single patient with sinusoidal obstructive syndrome (sos)/veno-occlusive disease (vod) after hematopoietic cell transplantation (hct) associated with either kidney and/or lung impairment that has not obtained a complete response (cr) or progressed in severity with standard doses of defibrotide.


Eligibility criteria:
inclusion criteria: * hct recipients (auto or allograft) * sos/vod as defined by cairo/cooke diagnostic criteria (1) (table 3) with either renal and/or pulmonary dysfunction as defined by cairo/cooke grading criteria (1) (appendix i). * unresponsive to standard defibrotide therapy as defined by at least one of the following: * patients with sos/vod failing to obtain a complete response (cr) defined by grade i or less by cairo/cooke grading criteria (1) (appendix i). this would therefore include patients with stable disease after at least 14 days of defibrotide or partial response after at least 21 days of defibrotide (25mg/kg/day). * progressive disease defined by progression of at least one grade or more from diagnostic grade as defined by cairo/cooke grading criteria (1) (appendix i) following at least 7 days of defibrotide (25mg/kg/day). * age 1 month - 75 years exclusion criteria: * patients who did not receive hct. * concomitant systemic anticoagulation (excluding central venous line management, fibrinolytic instillation for central venous line occlusion, management of intermittent dialysis or ultrafiltration of cvvh). * active bleeding and/or hemorrhage of at least grade 2 and above. * history of development of grade iii/iv anaphylaxis probably or directly secondary to defibrotide. * female patients who are pregnant or breast feeding.
impact of the techniques for intrathoracic esophagogastric anastomosis on outcome in ivor-lewis oesophagectomy

Conditions: Esophageal Cancer

Summary: the purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in ivor-lewis oesophagectomy.


Eligibility criteria:
inclusion criteria: * cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage i, ii, or iii. * received no previous treatment for esophageal cancer * adequate bone marrow, liver and kidney function * patients must be able to understand the nature consent of the study and give written informed consent. exclusion criteria: * age \< 18 years * history of significant heart disease * inoperable on the basis of co-existent medical problems
"myplan" - individualized planned eating patterns for adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to test the acceptability and effectiveness of an individualized eating strategy as part of diabetes self-management to improve glycemic levels among youth with type 1 diabetes (t1d) and suboptimal glycemic management. investigators will assess participant acceptability of and adherence to a 6-month individualized eating strategy ("myplan") characterized by approximate day-to-day consistency in the frequency and timing of meals and snacks and distribution of carbohydrate throughout the day. within-individual change in glycemic levels between baseline and 6-months of the study will also be compared. the goal of the study is to inform the design of a future randomized clinical trial to test the addition of the myplan eating strategy to ongoing diabetes clinical care among youth with t1d.

this is a pilot, single-arm clinical trial to assess whether "myplan" is an acceptable and effective dietary strategy to be included in future fully powered trials aimed at optimizing diabetes outcomes in youth with t1d. youth and guardian dyads will be enrolled for a total of 6 months, during which time dyads will be counseled to follow an individualized eating pattern ("myplan") defined by five eating behavior goals: 3-4 meals per day and 1-2 optional snacks; eating occasions no less than 2 hours or greater than 4 hours apart; target carbohydrate ranges for each eating occasion; no post-dinner snacking; eating occasion within 1-2 hours of waking. the plan, including the eating behavior goals, will be tailored to youth and family routines and preferences. registered dieticians will support participant adherence to the plan via telehealth counseling sessions on a weekly basis for the first 2 months followed by bi-weekly sessions for 4 months. investigators will assess a) acceptability of the eating pattern and counseling strategy according to youth and guardians; b) youth adherence to the five eating behavior targets; c) change in youth glycemic levels between baseline and 6-months.

Eligibility criteria:
inclusion criteria: * youth 12-17 years old * history of t1d of at least one year * hba1c 7.5-11% * guardian willing to also participate * english as preferred language exclusion criteria: * youth with other metabolic disorders, unstable thyroid disease, diagnosed eating disorders, prohibitively strict dietary restrictions, or those with other serious condition that renders participation inappropriate. * females who are pregnant, breast feeding, planning to become pregnant during the study period or delivered a baby in the last 12 months. * unwillingness to follow a personalized eating plan for 6 months or complete myfitnesspal logs at least 3 days/week throughout the study.

Keywords: diabetes mellitus, type 1 feeding behavior glycemic control
proparacaine and mydriatic eye drops

Conditions: Pain; Retinopathy of Prematurity

Summary: in this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in neonatal intensive care unit (nicu) infants.

a. randomization of subjects: infants will be randomized to receive proparacaine versus no intervention based on computerized randomization performed by our statistician. due to the lack of a placebo group, practitioners present at the time of examination will not able to be blinded to group assignment. each infant will only be enrolled for one examination. b. monitor setup/application: the central nervous system (cns) neonatal neurological monitor (moberg research) will be used to videotape each patient encounter and record vital sign information during the study period. the cns monitor will record physiologic variables indirectly via cables attached to the bedside monitor. before scheduled eye drop administration takes place, the appropriate connections between the bedside monitor and cns monitor will be made in order to continuously record heart rate, respiratory rate, pulse oximetry, and blood pressure. a video camera attached to the cns monitor will also be positioned to capture the subjects' facial activity and gross body movements. the monitor will be set up with enough time prior to eye drop administration such that baseline data can be collected before any intervention is performed. in addition, a video recording of the method of eyedrop administration will be assessed. the monitor will remain in place up to 5 minutes after completion of eye drop administration. c. eye drop administration: the cns monitor will be in place at least 3 minutes prior to administration of any eye drops to record baseline data on the infant. one drop of proparacaine anesthetic ophthalmic solution will be applied to each eye of infants randomized to receive proparacaine prior to the mydriatic eye drops. at least 30 seconds and no longer than 5 minutes after administration of proparacaine, the mydriatic eye drops will be given as per routine standard practice for ophthalmologic examinations in the nicu.

Eligibility criteria:
inclusion criteria: * infants admitted to the pennsylvania hospital nicu who require an ophthalmologic examination. exclusion criteria: * infants with congenital anomalies, seizures, or other neurologic conditions or malformations that may alter the pain response * infants with corneal abrasions, corneal ulcers or other relative or absolute contraindications to proparacaine administration

Keywords: pain retinopathy of prematurity neonates
web-based support during pregnancy and early motherhood in women with type 1 diabetes (modiab-web)

Conditions: Diabetes Type 1; Pregnancy; Early Motherhood

Summary: the aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes. type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing. there is need for extended support from both health care professionals and peers. web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes. a web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers. in a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in sweden. a control group will receive standard care (usual care). total n = 160. primary outcomes are well-being questionnaire and diabetes empowerment scale. the intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.


Eligibility criteria:
inclusion criteria: * women with type 12 diabetes, included in early pregnancy (first trimester) exclusion criteria: * women who are illiterate, or do not read and speak swedish
a long-term study of kps-0373 in patients with spinocerebellar degeneration (scd)

Conditions: Spinocerebellar Degeneration

Summary: the purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of kps-0373 in scd patients


Eligibility criteria:
inclusion criteria: * japanese scd patients with ataxia exclusion criteria: * patients with secondary ataxia * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: spinocerebellar degeneration (scd) thyrotropin-releasing hormone (trh) spinocerebellar ataxia (sca)
innovations in hiv testing (ti)

Conditions: Human Immunodeficiency Virus

Summary: the investigators propose to improve hiv prevention and care through expanding hiv testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

study description brief summary: the investigators propose to improve hiv prevention and care through expanding hiv testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. detailed description: the investigators propose to improve hiv prevention and care through expanding hiv testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. in this study the investigators proposed two phases. the first phase, explained in this submission, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of hiv testing and hiv self-testing in the study population and 2) conducting observed hiv self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. the second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) choice of self-testing or clinic-based hiv counseling and testing (hct) or 2) clinic based hct. once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.

Eligibility criteria:
fgd inclusion criteria: * females and males aged 18 - 24 * able and willing to provide informed consent * residing in the selected villages observation inclusion criteria: * females and males aged 18 -24 * able and willing to provide informed consent * residing in the selected villages * not known to be hiv positive (not reporting a previous positive test)
tai chi after pulmonary rehabilitation in patients with copd: a randomized trial

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with copd that have recently completed a pulmonary rehabilitation program.


Eligibility criteria:
inclusion criteria: 1. copd defined as fev1 (forced expiratory volume in 1 second)/fvc (forced vital capacity) \<0.70 or chest ct evidence of emphysema 2. age \> 40 years 3. any severity of copd as defined by gold (global obstructive lung disease) stages 1, 2,3, or 4 4. completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry\* \*defined as attending 65% of the program's sessions with a minimum of 10 sessions exclusion criteria: 1. copd exacerbation requiring steroids, antibiotics, ed visit or hospitalization within the past 2 weeks unless physician deems subject at baseline 2. hypoxemia on walk test (o2 sat \< 85% on oxygen) 3. inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test 4. clinical signs of unstable cardiovascular disease (ie. chest pain on walk test) 5. severe cognitive dysfunction (documented mini-mental status exam ≤ 24) 6. non-english speaking 7. current regular practice of tai chi 8. current diagnosis of lung cancer or treated for lung cancer within the past 5 years 9. unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention

Keywords: chronic bronchitis emphysema pulmonary copd
effect of rtms in pathological gamblers

Conditions: Pathological Gambler

Summary: the gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs. in pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. the neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (dlpfc) (goldstein et al, 2001, volkow and goldstein, 2002). one therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rtms).

patients included in this study will have: * an anatomical brain mri (30 minutes). * two 20 minute sessions of rtms (placebo and active) of the left dlpfc, at the frequency of 10 hz. * visual analogue scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (pg-ybocs). * cognitive tests, to be carried out on a computer before and immediately after rtms sessions. * recording heart rate variability (hrv) to measure the autonomic nervous system (ans) activity as it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. the investigators based on previous studies evaluating one rtms session on craving in sud and used a crossover design to generate greater power.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of pathological gambling (dsm iv criteria) * first-time consultants. * without psychotropic treatment or treatment with a stable and unchanged for over a month. exclusion criteria: * presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil * pregnant women and patients with hearing disorders * personal history of epilepsy (untreated or poorly balanced) * focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious) * history of head trauma with loss of consciousness, * administration of drugs or substances lowering the seizure threshold * sleep deprivation, jet lag, or drug withdrawal. * participants with a problem of uncorrected visual acuity. * other current addiction (except tobacco, for reasons of feasibility). * current psychiatric comorbidity * treatment psychotropic introduced or changed for less than a month. * subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs

Keywords: pathological gambling rtms cognitive tests autonomic nervous system craving
a comparison between two post-operative dressings

Conditions: Surgical Incision

Summary: surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide. the ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms. in addition, it is often difficult for the patient to identify breaks in dressing integrity. this trial compares a post-operative dressing (drysee® inc. houston tx) with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing (tegaderm® + pad, 3m, st. paul, mn). the ideal dressing also allows the patient to shower without removing the dressing.

healthy subjects drawn from the general population. will undergo a 1.5cm incision on the volar forearm of each arm. the incision will be closed with streriostrips. the subject's incisions will then be randomized to receive either a tegaderm® + pad transparent film dressing or drysee® dressing with moisture detection. the incisions will be photographed three times per week. data on dressing wear time, integrity and adverse events will be collected every two days in the clinic.

Eligibility criteria:
inclusion criteria: 1. at least 18 years old. 2. subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements. exclusion criteria: 1. subject on an investigational drug or therapeutic device within 30 days of the study visit. 2. presence of a condition that pi considers will compromise the subject's ability to participate in the study. 3. known allergy to any of the dressings or their components. 4. the subject has a history of excessive bleeding. 5. the subject has a history of keloid formation.